A worker at Vedanta's new manufacturing site (via Vedanta)

Vedan­ta opens man­u­fac­tur­ing fa­cil­i­ty to pro­duce lead can­di­date as it heads for PhI­II

The mi­cro­bio­me start­up Vedan­ta, while still forg­ing ahead with the Phase III process for its Clostrid­ioides dif­fi­cile in­fec­tion can­di­date, has com­plet­ed a man­u­fac­tur­ing fa­cil­i­ty to pro­duce the drug.

Vedan­ta’s new 7,000-square-foot fa­cil­i­ties in Cam­bridge, MA, are de­signed to man­u­fac­ture clin­i­cal and com­mer­cial sup­plies for its port­fo­lio, in­clud­ing their oral c. dif­fi­cile can­di­date VE303.

The fa­cil­i­ty is an ex­ten­sion of the com­pa­ny’s ex­ist­ing man­u­fac­tur­ing ca­pa­bil­i­ties and can pro­duce mul­ti­ple drug can­di­dates, ac­cord­ing to Vedan­ta. It al­so has CGMP ca­pa­bil­i­ties to han­dle every­thing from clin­i­cal de­vel­op­ment to com­mer­cial launch. Man­u­fac­tur­ing is ex­pect­ed to kick off in Q4 of this year.

The cost of the fa­cil­i­ty and em­ploy­ment de­tails were not dis­closed to End­points News, though Vedan­ta did con­firm in an email that gov­ern­ment funds were giv­en to the com­pa­ny. The com­pa­ny is a fund­ed con­trac­tor of BAR­DA and sup­port went to Vedan­ta’s lead pro­gram and se­lect as­pects of the fa­cil­i­ty de­sign and com­mis­sion­ing, Vedan­ta said.

In Oc­to­ber of 2021, pos­i­tive Phase II re­sults trig­gered a $23.8 mil­lion op­tion from BAR­DA. The funds have been used to sup­port the can­di­date in sev­er­al ca­pac­i­ties in­clud­ing man­u­fac­tur­ing.

“This fa­cil­i­ty, com­bined with the ex­per­tise and tal­ent of our team, is de­signed to man­u­fac­ture our mi­cro­bio­me prod­uct can­di­dates as stan­dard­ized com­po­si­tions with con­sis­tent qual­i­ty at­trib­ut­es at a large scale,” Vedan­ta CEO Bernat Olle said in a state­ment.

The com­pa­ny’s first pro­duc­tion runs at the new fa­cil­i­ty will sup­ply a planned Phase III study of VE303, but the time­line of that tri­al has not been dis­closed to End­points.

Vedan­ta has been on the charge as of late with its lead can­di­date. In 2021, it wrapped up a $68 mil­lion Se­ries D raise, which in­clud­ed a $25 mil­lion eq­ui­ty in­vest­ment from Pfiz­er. The com­pa­ny net­ted a $45.5 mil­lion C round in 2019.

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David Reese, Amgen R&D chief

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Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

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